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

Catalog Number RBYPOD4

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal portion of the embolization coil.Conclusions: evaluation of the returned pod4 revealed offset coil winds on the proximal end of the embolization coil.If the pod4 is forcefully advanced or retracted against resistance, the coil winds may compress resulting in the most proximal portion of the coil to be damaged.During functional testing, the pod4 was re-sheathed and resistance was experienced while attempting to advance the pod4 out of its introducer sheath.The offset coil winds likely contributed to the resistance experienced during functional testing.The lantern and diagnostic catheter identified in the complaint were not returned for evaluation; therefore, the root cause of the initial resistance experienced during the procedure could not be determined.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

The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using pod4s.During the procedure, the physician made multiple attempts to advance a pod4 into the target vessel using a lantern delivery microcatheter (lantern) and diagnostic catheter; however, it was not successful.It was reported that the pod4 would not advance further after approximately 5 cm was left to deploy.Therefore, the pod4, lantern, and diagnostic catheter were removed.Upon removal, the physician noticed that the embolization coil was broken but still attached to the pusher assembly.The procedure was completed using a new pod4, lantern, and diagnostic catheter.It was reported that since a longer sized diagnostic catheter was used to complete the procedure, a longer sized lantern was also needed.There was no report of an adverse effect to the patient.

• 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: 9083137
• MDR Text Key: 159030039
• Report Number: 3005168196-2019-01758
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173614
• 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: 01/01/2005,08/19/2019

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: RBYPOD4
• Device Lot Number: F81516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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
• Patient Age: 68 YR