MAUDE Adverse Event Report: PENUMBRA, INC. POD 4; HCG, KRD

Catalog Number	RBYPOD4
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing coil embolization in the inferior phrenic artery using pod4s.During the procedure, the physician felt resistance while advancing and withdrawing a pod4 at an area approximately 10 cm from the end of the lantern.Therefore, the lantern and pod4 were removed.Next, the physician attempted to remove the pod4 from within the lantern outside the patient; however resistance was met; subsequently the pod4 broke and the physician flushed the pod4 out of the lantern.The lantern was reinserted and the procedure was completed using three ruby coils, four other coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked and fractured in multiple locations.The embolization coil was detached from its pusher assembly and not returned for evaluation.The pull wire was distal to the distal detachment tip (ddt) and remained within the alignment feature.Conclusions: evaluation of the returned pod4 revealed that the pusher assembly was kinked and fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kinked device is forcefully manipulated, damage such as a fracture may result.The lantern and the pod4 embolization coil identified in the complaint was not returned for evaluation.Therefore, the root cause of the reported resistance could not be determined.Further evaluation of the returned pod4 revealed that the embolization coil was detached from its pusher assembly.If the pusher assembly fractured segments are separated, the pull wire may retract out of the ddt, which allows the embolization coil to detach from its pusher assembly.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.

• Brand Name: POD 4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8888868
• Report Number: 3005168196-2019-01580
• Device Sequence Number: 2683393
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2026
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F82810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005