MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE068KIT

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a medical procedure using a penumbra system ace 68 kit, the physician reported that the penumbra system ace 68 reperfusion catheter (ace68) was missing its peelable sheath.The ace68 was therefore not used in the procedure.The procedure was completed using another kit.

Manufacturer Narrative

Results: the returned ace68 was undamaged.The peelable sheath and shipping mandrel were missing from the packaging.Conclusions: evaluation of the returned ace68 packaging confirmed that the peelable sheath was missing from the packaging.Further investigation revealed that a small pouch which contain a peelable sheath and a shaping mandrel was missing from the returned ace68 packaging.The returned packaging was opened; therefore, the root cause of the missing components could not be determined.Penumbra catheters 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.Section h.Box 6.Results code 1: 4247 - investigation was performed on the returned catheter (ace68); however due to missing items from the packaging, a complete investigation was unable to be performed.Section h.Box 6.Conclusions code 1: 4316 ¿ the investigation findings do not lead to a clear conclusion about the cause of missing components.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8619280
• MDR Text Key: 145370989
• Report Number: 3005168196-2019-00980
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F86600
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1