MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Catalog Number RBYPODJ15

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

While attempting to introduce a pod packing coil (podj coil) into the hub of a lantern delivery microcatheter (lantern) for a coil embolization procedure in the gastroduodenal artery (gda), the physician noticed that the podj coil was already detached from its pusher assembly and had fallen out of its introducer sheath, onto the surgical table.The podj coil unintentionally detached prior to use and was not introduced through the hub of the lantern.Therefore, the podj coil was not used for the procedure.The procedure was successfully completed using a new podj coil and the same lantern.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6068460
• MDR Text Key: 58820615
• Report Number: 3005168196-2016-01532
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F70491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1