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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
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 a coil embolization procedure using pod packing coils (podjs).During the procedure, a podj would not advance within its introducer sheath; therefore, it was removed.The physician then attempted to advance the podj out of its introducer sheath and into a bowl of saline but it would not advance.The procedure was therefore completed using a new podj.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.Bends and kinks were present along the pusher assembly approximately 5.0, 7.5, 18.5, 85.0, 97.0, 110.0, 123.5 and 128.5 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned podj revealed the pusher assembly mid-joint was proximal to the introducer sheath friction lock and a pusher assembly kink.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath which allows it to seat properly on the mid-joint.If the mid-joint is retracted proximal to the friction lock, resistance may be experienced during advancement.If the device is mishandled while advancing against resistance, damage such as a kink may occur.During functional testing, the introducer sheath was reseated onto the mid-joint.Subsequently, the podj was advanced through its introducer sheath and a demonstration microcatheter without issue.Further evaluation revealed additional pusher assembly bends and kinks.These bends and kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.H3 other text : placeholder.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8612076
• Report Number: 3005168196-2019-00955
• Device Sequence Number: 1808233
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019
• 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: 11/26/2025
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F80738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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