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

Catalog Number RBYPODJ30

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pusher assembly was kinked approximately 11.0 cm from the proximal end where the wire enters the packaging hoop.There was minor bends on the length of the podj pusher assembly.Conclusions: evaluation of the returned podj revealed a kink on its proximal end where the wire enters the packaging hoop.This damage was likely a result of retracting the device from the hoop at extreme angles.Further evaluation revealed minor bends on the length of the catheter.This damage was likely incidental and occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

During preparation for a coil embolization procedure, the hospital technician inadvertently kinked the pusher assembly of the pod packing coil (podj) upon removal from the packaging.The damage to the podj was found prior to use.Therefore, the podj was not used in the procedure.The procedure was completed using new ruby and pod packing coils.

• 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: 7562172
• MDR Text Key: 109828226
• Report Number: 3005168196-2018-01084
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F81887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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