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

Catalog Number RBYPOD8

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

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.This report is associated with mfr report number: 3005168196-2017-01238.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils and pod8's.During the procedure, the physician successfully deployed and detached initial penumbra coils into the target vessel using a non-penumbra microcatheter.While attempting to advance a new ruby coil through the microcatheter, the physician experienced resistance and subsequently, the ruby coil pusher assembly became bent.Therefore, the ruby coil was removed and it was observed that the microcatheter appeared to be bent.The physician then deployed and detached additional penumbra coils into the target vessel using the same microcatheter.While attempting to pull a new pod8 out of its packaging hoop, the physician inadvertently bent the pod8 pusher assembly.Therefore, the pod8 was set aside and the procedure was successfully completed using four ruby coils, two pod packing coils (podj's), one pod6 and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 6744416
• MDR Text Key: 81086666
• Report Number: 3005168196-2017-01239
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F74232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• 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