MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-01 for ARROW CLAMP CATHETER COMPONENT EU-00007-CC manufactured by Arrow International Inc..
[84349126]
Concomitant medical products: 017-00313, (b)(4). The device is not intended for sale in the us. Similar device sold in the us. According to the correspondence received from the user facility, the cvc was sutured only at the clamp/fastener and not at the hub. This is contrary to the product instructions for use, which requires suturing at the junction hub as the primary suture site, with the clamp/fastener as the secondary suture site. A companion report (mdr# 3006425876-2017-00313) for the same incident has been filed for the cvc set noted in concomitant medical products.
Patient Sequence No: 1, Text Type: N, H10
[84349127]
The customer alleges that the catheter shoved out of the fastener. The customer reports that they only put a suture on the clamp and no suture on the hub of the primary catheter itself. The catheter used by the user facility is for catalog# eu-15703-cvt cvc set and is documented in mdr# 3006425876-2017-00313. During shifting of the patient, it was noted that the line had slipped out, causing an interruption in the administration of inotropic medication. A new catheter was placed (femoral placement). After dislocation of the initial cvc, the patient's blood pressure decreased such that the patient needed resuscitation. During resuscitation a bleed occurred. The thorax was re-opened. The patient clinically worsened and died.
Patient Sequence No: 1, Text Type: D, B5
[105824280]
(b)(4). A device history record (dhr) review was performed and no relevant findings were identified. The reported complaint that catheter migrated could not be confirmed as a sample was not provided for evaluation. Although a sample was not provided for this complaint, the customer confirmed that the cvc was not fixed according to the instructions for use (ifu). The catheter was sutured and secured using only the box clamp, instead of using the triangular juncture hub as the primary suture site and the box clamp as a secondary suture site as necessary. Based on the information received, the primary cause of this complaint is operational context. Teleflex has sent the customer a letter that explains "how to secure the catheter".
Patient Sequence No: 1, Text Type: N, H10
[105824281]
The customer alleges that the catheter shoved out of the fastener. The customer reports that they only put a suture on the clamp and no suture on the hub of the primary catheter itself. The catheter used by the user facility is for catalog# eu-15703-cvt cvc set and is documented in mdr# 3006425876-2017-00313. During shifting of the patient, it was noted that the line had slipped out, causing an interruption in the administration of inotropic medication. A new catheter was placed (femoral placement). After dislocation of the initial cvc, the patient's blood pressure decreased such that the patient needed resuscitation. During resuscitation a bleed occurred. The thorax was re-opened. The patient clinically worsened and died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2017-00336 |
| MDR Report Key | 6837989 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-01 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-09-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW CLAMP CATHETER COMPONENT |
| Generic Name | IV SECUREMENT DEVICE |
| Product Code | PUK |
| Date Received | 2017-09-01 |
| Catalog Number | EU-00007-CC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-01 |