MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-13 for MELPHALAN/HEPATIC DELIVERY SYSTEM 400018 702005 manufactured by Delcath Systems, Inc..
[4845937]
During a compassionate use case performed under an individual-patient ind sponsored by dr. (b)(6), the following occurred: during the hepatic artery infusion of melphalan hydrochloride for injection, movement of the double balloon catheter (provides isolation of the hepatic effluent) was observed relative to the sheath. Fluoroscopy indicated that the cephalad balloon was no longer fully inflated. The procedure was aborted (drug infusion stopped and catheters removed). Patient did not receive the post-infusion washout. The planned melphalan dose was 170 mg, due to the aborted procedure only approximately 130 mg was administered. The cephalad balloon was examined ex vivo and had a leak at the proximal bond with the catheter shaft. After the procedure, the patient received neulasta as per usual post-procedure protocol. As of (b)(6), the patient reported to be doing well with no abnormal lab or ecog values.
Patient Sequence No: 1, Text Type: D, B5
[12257612]
Upon receipt of double balloon catheter complaint sample, delcath inspected the catheter under 20x magnification to evaluate the bond joints of the cephalad balloon: with the balloon inflated with air, on the proximal balloon joint, there was evidence of peeling of the bond approximately 270 degrees around the bond circumference. At one point, the bond peel reaches to the outer bond edge adjacent to the urethane transition and leaks when the balloon is pressurized. Visual inspection indicated that the catheter shaft in the balloon bond area appeared shiny, where a properly cleaned shaft has a dull appearance from the alcohol wipe. Based upon the investigation, the root cause for catheter defect is a manufacturing workmanship issue related to cleaning of the catheter shaft prior to balloon bonding. The catheter shaft appears to have been cleaned, but not adequately in the area where the proximal bond of the cephalad balloon is located. The inadequate catheter shaft preparation led to a compromised balloon bond that manifested as peeling of the bond joint during use and eventual loss of any bond between the catheter and balloon in one small location on the bond circumference. The potential for inadequate cleaning of the catheter shaft prior to balloon bonding was identified as a potential manufacturing process failure during delcath's development of the product and controls were put in place. The catheter involved in the event, is the first known catheter with this defect that was released despite the controls put in place to capture catheters with this defect. At this time, there is no evidence to suggest that this defective unit is anything other than an isolated event. Nevertheless, capa (b)(4) has been opened to address the controls to ensure adequate catheter shaft cleaning prior to balloon bonding.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008822486-2014-00001 |
| MDR Report Key | 4013979 |
| Report Source | 05 |
| Date Received | 2014-02-13 |
| Date of Report | 2014-01-15 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-01-17 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2014-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KARIN RADOVICH |
| Manufacturer Street | 566 QUEENSBURY AVE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187438892 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MELPHALAN/HEPATIC DELIVERY SYSTEM |
| Generic Name | DOUBLE BALLOON CATHETER |
| Product Code | FLD |
| Date Received | 2014-02-13 |
| Returned To Mfg | 2014-01-17 |
| Model Number | 400018 |
| Catalog Number | 702005 |
| Lot Number | L001330 |
| Device Expiration Date | 2014-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DELCATH SYSTEMS, INC. |
| Manufacturer Address | 566 QUEENSBURY AVE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-13 |