MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number RBYPOD5

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 device was implanted in the patient.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod5 coils.During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the target vessel using other manufacturers'' sheath and microcatheter and then attempted to place a pod5 coil into the aneurysm.Although two-thirds of the pod5 coil was placed into the aneurysm, it was not deploying properly.After the physician retracted and advanced the pod5 coil several times in order to reposition the coil, it unintentionally detached.With two-thirds of the coil already in the aneurysm, the physician pushed the rest of the coil in using the pod5 coil pusher assembly.The procedure was then completed using another manufacturer's coils, a new pod coil and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: POD5
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5815647
• MDR Text Key: 50311511
• Report Number: 3005168196-2016-01047
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F68516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 48 YR