MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number RBYPOD4

Device Problems Positioning Failure (1158); Retraction Problem (1536); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pod4 pusher assembly.The embolization coil was intact with its pusher assembly.The outer diameter (od) of the embolization coil was measured and found to be within specification.The introducer sheath was ovalized approximately 1.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed that the pod4s introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the introducer sheath is forcefully gripped during insertion or while advancing the embolization coil into the microcatheter, damage such as this may occur.The od of the embolization coil was measured and found to be within specification.The root cause of the reported resistance during removal of the device could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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

The patient was undergoing a coil embolization procedure to treat an abdominal bleed using pod4s.During the procedure, while attempting to place a pod4 as an anchoring coil, the physician did not mention resistance while advancing the coil through the non-penumbra microcatheter; however, the pod4 was unable to be deployed because the microcatheter was not well positioned so the physician decided to remove the pod4.While attempting to retract the pod4, the physician encountered resistance and felt that the pod4 had unintentionally detached.Therefore, the physician removed the microcatheter containing the pod4 from the patient.Next, the pod4 pusher assembly was pulled out of the microcatheter and it was observed that the coil came out intact.The microcatheter was then flushed and re-inserted into the patients body.Thereafter, the procedure was completed using a new penumbra coil 400 (pc400) and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Pma/510(k) was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.

• Brand Name: POD4
• 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: 6795741
• MDR Text Key: 82769352
• Report Number: 3005168196-2017-01318
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F68771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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