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

Catalog Number	RBYPOD4
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery using pod4s.During the procedure, the physician placed the pod4 in the target vessel using a non-penumbra microcatheter.While advancing another pod4 through the microcatheter, the physician gradually felt resistance and subsequently, the pod4 would not advance beyond the middle of the microcatheter; therefore, it was removed.The procedure was completed using another pod4, four penumbra coil 400s (pc400s) and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly was kinked approximately 7.5 cm, 8.5 cm, 30.5 cm, 78.0 cm and 122.5 cm from the proximal end.The embolization coil had offset coil winds and was intact with the distal detachment tip (ddt) of the pusher assembly.Due to the returned condition of the pod4, a demonstration introducer sheath was unable to be loaded onto the device and, therefore, the pod4 could not be functionally tested.Conclusions: evaluation of the returned pod4 revealed an embolization coil with offset coil winds and a kinked pusher assembly.The reported complaint mentioned that resistance was experienced.If the device is forcefully advanced against resistance, damage such as kinks and offset coil winds may occur.The offset coil winds likely contributed to the reported gradual resistance and inability to advance the device.The microcatheter used in the procedure was not returned for evaluation and the root cause of the initial resistance 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.

• Brand Name: POD 4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8206756
• Report Number: 3005168196-2018-02539
• Device Sequence Number: 2026715
• 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): 12/02/2018
• 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: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/02/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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