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

Model Number RBYPCLP60

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01247.

Event Description

The patient was undergoing a coil embolization procedure using packing coil lps, ruby coil lps and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, while attempting to position the packing coil lp into the target location, the packing coil lp broke.Therefore, the packing coil lp was removed.Next, while the physician attempted to advance a ruby coil lp within its introducer sheath, the physician experienced resistance.Subsequently, the physician had difficulty advancing the ruby coil lp from the starting position within its introducer sheath.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp and a new packing coil lp.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded and is no longer available for return.Therefore, 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 number: 3005168196-2021-01247.H3 other text : placeholder.

• Brand Name: PACKING COIL LP
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11935536
• MDR Text Key: 254297323
• Report Number: 3005168196-2021-01246
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021952
• UDI-Public: 00815948021952
• Combination Product (y/n): Y
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPCLP60
• Device Catalogue Number: RBYPCLP60
• Device Lot Number: F100694
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR