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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistance wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned podj revealed that the sr wire was fractured.The introducer sheath friction lock has a small inner diameter (id) than the rest of the sheath, which allows the sheath to seat properly on the pusher assembly mid-joint.The proximal end of the embolization coil has a larger outer diameter (od) than the introducer sheath friction lock.If the embolization coil is retracted through the introducer sheath friction lock, the embolization coil will likely fracture.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod packing coils (podj's).During the procedure, the physician successfully deployed and detached a ruby coil and a podj in the target vessel using a non-penumbra microcatheter.The physician then experienced resistance and was unable to advance a podj within its introducer sheath and, therefore, the podj was removed.However, while retracting the podj through its introducer sheath, the podj broke.The procedure was completed using additional coils and the same microcatheter.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: 7679152
• Report Number: 3005168196-2018-01363
• Device Sequence Number: 19044768
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: Health Professional
• Device Expiration Date: 01/17/2026
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F81512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 80