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	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2017-01157, 3005168196-2017-01158, 3005168196-2017-01159, 3005168196-2017-01161.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastro-duodenal artery (gda) bleed using pod packing coil (podj).During the procedure, after advancing about 55 cm of podj in the target vessel using a non-penumbra microcatheter, the physician reached the ostium of the gda and ran out of space to deploy the remaining five centimeter.Therefore, the physician decided to remove the podj.While attempting to retract the podj, the physician did not mention resistance; however, the podj unintentionally detached from the pusher assembly with fifteen centimeter of the coil in the microcatheter.After attempting to remove the podj and the microcatheter under aspiration, the podj ended up in the common hepatic artery.Therefore, the physician used a micro snare device with a 5f non-penumbra catheter to remove the detached podj from the patient's body.It was reported that it took approximately 30 minutes to snare the coil while adding significant fluoroscopy time to the case.The physician then inserted a new non-penumbra microcatheter in the target vessel and attempted to load a new podj; however, resistance was encountered and the podj would not advance though the microcatheter.Therefore, the physician removed the podj.Next, the physician attempted to load two additional podj's coils and a ruby coil through the same microcatheter; however, resistance was encountered and both podj's and ruby coil would not advance through the microcatheter.Therefore, the physician removed all the coils and the procedure was completed using seven non-penumbra coils and the same microcatheter without further issues.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: 6710749
• Report Number: 3005168196-2017-01160
• Device Sequence Number: 197796
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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: 03/11/2025
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F74949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR