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

Catalog Number	RBYPODJ15
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	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 131.5 and 142.0 cm from the proximal end.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned device revealed that the pod packing coil (podj) pusher assembly was kinked, fractured, and the embolization coil was detached.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kink is attempted to be straightened, damage such as a fracture may occur.Further evaluation of the returned device revealed that the embolization coil was detached from its pusher assembly.This type of damage likely occurred due to the separation of the two fractured segments, which caused the pull wire to be retracted out of distal detachment tip (ddt), and resulting in the coil detaching from its pusher assembly.Since the podj was reportedly removed from the procedure with no mention of detachment, the detachment of the coil was likely incidental to the reported resistance issues.The pxslim referred to in the complaint was not returned for evaluation.Penumbra coils and catheters 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 to treat a dural arteriovenous fistula (d-avf) using pod packing coils (podjs).During the procedure, while attempting to advance a podj through a px slim delivery microcatheter (px slim), the physician experienced resistance; therefore, it was removed.The procedure was completed using a new podj and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7286789
• Report Number: 3005168196-2018-00375
• Device Sequence Number: 1890347
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: 07/13/2024
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F70628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/21/2018
• 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