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 2020-02-24 for 20/30 PRIORITY PACK 20/30 INDEFLATOR 1003327 manufactured by Abbott Vascular.
[180711160]
The device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[180711161]
It was reported that the procedure was to treat a 97% stenosed, moderately tortuous, and heavily calcified de novo lesion in the proximal left circumflex artery. Indeflator 20/30 was used for pre-dilatation by a secured connection to the hub of a 2. 0x15mm trek balloon dilatation catheter (bdc). However, during the attempt to inflate the bdc, the pressure gauge seemed very slow to reach 8 atmospheres (atm), the contrast from the indeflator syringe was very slowly to fill into the bdc and bubbles were noted inside the bdc. The connection at the hub of the bdc and indeflator was verified; there was no leak noted. A second inflation was attempted but again the same indeflator was very slow to reach 10 atm. A new indeflator 20/30 was successfully used to inflate the same 2. 0x15mm trek bdc with a normal pressure rate to reach 8-10 atm and no bubbles were found inside of balloon during inflation. The procedure was successfully completed with the new indeflator 20/30, 2. 0x15mm trek bdc, non-abbott device and nc trek 2. 75x15mm. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01736 |
| MDR Report Key | 9747541 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-02-24 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 20/30 PRIORITY PACK 20/30 INDEFLATOR |
| Generic Name | ACCESSORIES |
| Product Code | MAV |
| Date Received | 2020-02-24 |
| Model Number | 1003327 |
| Catalog Number | 1003327 |
| Lot Number | 60205994 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |