MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PORT & CATHETER, IMPLANTED

Catalog Number	H965440150
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics for evaluation.The investigation is still in process.Upon completion, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, bioflo port was placed (b)(6) 2018.Patient receives ivig and they were not able to get a blood return.The patient was sent for a contrast study, and a hole was found in the side of the catheter.The device was removed and has been returned to angiodynamics.
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lots (5264487) for item number (b)(4) for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the bioflo port product family and the failure mode "catheter fractured." no adverse trend was identified.The used port/catheter assembly was returned for evaluation.As reviewed, the septum had multiple puncture marks.The catheter had been trimmed to 4 cm mark and attached to the port at the 17 cm mark.Functional check: the single lumen port was tested for leak.The port did not leak.The catheter was tested for leak - it also did not leak.No hole was found.Dimensional check: the catheter was measured (id and od) and found to be within specification.The reported complaint description was not confirmed for hole/fracture in catheter.No manufacturing non-conformances were observed during sample evaluation the catheter tubing met visual, functional and dimensional specifications, and no hole was noted to the catheter tubing.Based on the evaluation performed on the returned sample, the root cause for the reported complaint is inconclusive.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8173278
• Report Number: 1317056-2018-00233
• Device Sequence Number: 1747776
• Product Code: LJT
• UDI-Device Identifier: H965440150
• UDI-Public: H965440150
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: H965440150
• Device Lot Number: 5264487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention