MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number RBYPOD8

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pod8 pusher assembly was fractured approximately 5.0 cm from the proximal end.Conclusions: evaluation of the returned pod8 revealed it was fractured near its proximal end.This damage may have occurred due to forceful handling of the pod8 during removal from the retainer clip and packaging hoop.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 found that the pusher wire of the pod8 was bent near the detachment zone upon removal from the packaging.The damage to the pod8 was found prior to use; therefore, it was not used in the procedure.The procedure was completed using a new pod8.

• Brand Name: POD8
• 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: 6911806
• MDR Text Key: 89615408
• Report Number: 3005168196-2017-01731
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2017

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
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F73902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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