MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; INTRAVASCULAR THERAPEUTIC CATHETER

Catalog Number	H965464701
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the used catheter will be returned to angiodynamics for evaluation, it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, a 4f midline catheter which had been placed on (b)(6) 2017 was flushed prior to the patient going to ct on (b)(6) 2017.A pinhole leak was noted on the extension leg and the catheter was removed.The patient condition was reported as "unaffected." it has been indicated that the used catheter will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The august 2017 angiodynamics complaint report was reviewed for the bioflo midline product family and the failure mode "extension leg - hole proximal to suture wing." no adverse trend was identified.The end user's reported complaint description of "leaked on clear tubing" [hole in extension leg tubing] is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Angiodynamics' manufacturing process controls for the bioflo midline include a guidewire insertion test to verify lumen patency followed by air leak testing to insure the catheters do not leak.Additional visual inspections for damage or defects are also performed.The directions for use (dfu) packaged with the bioflo midline contain the following precautions/warnings: "warnings: do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced." ((b)(4)).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: INTRAVASCULAR THERAPEUTIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6813964
• Report Number: 1317056-2017-00067
• Device Sequence Number: 19349434
• Product Code: FOZ
• UDI-Device Identifier: H965464701
• UDI-Public: H965464701
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: H965464701
• Device Lot Number: 5200461
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1