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

Catalog Number	RBYPOD5
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was returned detached from its pusher assembly with the proximal constraint sphere intact.Conclusions: evaluation of the returned pod5 revealed that the embolization coil was detached from its pusher assembly.However, the pod5 pusher assembly, introducer sheath and the px slim referred to in the complaint description were not returned to penumbra for evaluation.Therefore, the root cause of the reported resistance could not be determined.Penumbra catheters and 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 or Problem Description
The patient was undergoing a coil embolization procedure using pod5s.During the procedure, the physician felt resistance and was unable to advance a pod5 out of its introducer sheath and into a px slim delivery microcatheter (px slim).The pod5 was therefore removed, and the procedure was completed using the same px slim and a pod packing coil (podj).There was no report of an adverse effect to the patient.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7491783
• Report Number: 3005168196-2018-00961
• Device Sequence Number: 18915597
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 04/11/2018

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: Physician
• Device Expiration Date: 06/11/2025
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F77643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR