MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CORSAIR PRO XS; PERCUTANEOUS CATHETER

Catalog Number	CSR150-21S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4), registration number: (b)(4).The corsair pro xs microcatheter was returned with the concomitant guide wire inside.The separated tip approximately 3mm long was remaining on the guide wire and located at approximately 15mm from the wire tip.Due to accumulated torsion generated with torquing manipulation, strands on the catheter shaft were disarranged, proximal part of the catheter tip was twisted, and the coil of the concomitant guide wire was loosened.Circumferential helical scratches were observed at the torn end of the catheter tip, indicating that some hard object most likely calcified plaque was trapping the tip during manipulation, and made the tip twist off.The torn end of the separated tip was circumferentially abraded to a great degree.At the very distal end of the tip there was a longitudinal indentation.Lot history review on both devices revealed no anomaly relating to the reported event.No other similar product experience report was received from either lot.Based on the obtained information and investigation outcome, it was presumed that torsion generated with torquing manipulation had contributed to tip separation of the returned caravel microcatheter.The applied stress would exceed the product design limit when the tip was being caught and restricted its movement most likely by calcified plaque, twisting the tip to separate.It was concluded that this event was not attributed to product quality.Observed tip damage was too severe to completely rule out a possibility that some fragments might be left in the patient.Instructions for use (ifu) states: warnings: do not use this microcatheter in advanced calcified lesion; warnings: if any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear.If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the operation while the cause of the problem is not identified may cause damage to or separation of the catheter, and damage the blood vessel.Life-threatening adverse events may occur.).Warnings: always hold the connector with one hand and turn the microcatheter carefully while regularly releasing the accumulated torsion of the microcatheter.Never turn the microcatheter continuously while holding the connector with both hands, or use any other means to apply force.When releasing the accumulated torsion, be sure to open the hemostatic valve on the y-connector.Do not turn the microcatheter in the same direction, either clockwise, or counterclockwise, for more than 10 consecutive turns.(continuing rotation may damage or break the microcatheter or damage the blood vessels.In the worst case, life-threatening adverse events may occur.), and malfunction and adverse effects: separation.
Event or Problem Description
It was reported that the tip of an asahi corsair pro xs microcatheter separated during a pci to treat a cto in the coronary artery.The catheter was crossing a septal channel when it got stuck in the septal and distal 1mm of the tip snapped off.The separated tip was married to end of the guide wire and caught enough to get back into a guide catheter and the physician was able to trap it out.It was reported that the tip of an asahi corsair pro xs microcatheter separated during a pci to treat a cto in the coronary artery.The catheter was crossing a septal channel when it got stuck in the septal and distal 1mm of the tip snapped off.The separated tip was married to end of the guide wire, caught enough to get back into a guide catheter, and the physician was able to trap it out.

• Brand Name: CORSAIR PRO XS
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10782576
• Report Number: 3003775027-2020-00164
• Device Sequence Number: 2960576
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)221130(10)191224K181
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K182420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CSR150-21S
• Device Lot Number: 191224K181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other