MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number	CAT8STR85
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
His device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff found the distal tip of the indigo system aspiration catheter 8 (cat8) to be ovalized in two points upon removal from packaging.The damage to the cat8 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat8.
Additional Manufacturer Narrative
Results: the indigo system aspiration catheter 8 (cat8) was kinked approximately 52.0 cm from the hub.The cat8 was ovalized approximately 80.5 and 86.0 cm from the hub.During functional testing, a 0.088¿ stainless steel was advanced through the hub of the cat8.Resistance was encountered as the mandrel met the proximal kink in the catheter shaft and the mandrel could not be advanced any further.Conclusions: evaluation of the returned cat8 confirmed that the distal tip was ovalized.If the distal tip of the catheter is forcefully pinched or gripped upon removal from its packaging, damage such as ovalization at the distal tip may occur.Further evaluation of the returned cat8 revealed additional ovalization along the catheter shaft.This ovalization may have occurred due to retracting the device from its packaging at an extreme angle during removal from its packaging or packaging the device for return to penumbra.Penumbra 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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8557770
• Report Number: 3005168196-2019-00821
• Device Sequence Number: 2430961
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019
• Report Date (Section F): 01/01/2005

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: 02/25/2021
• Device Catalogue Number: CAT8STR85
• Device Lot Number: F82063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005