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

Catalog Number	CSR135-21S
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	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: (b)(4), registration number: (b)(4).The corsair pro xs microcatheter was returned for evaluation.The concomitant non-asahi guide wire was inserted inside and about 12.5cm of the distal wire was out of the catheter tip.The separated tip of the microcatheter was locate on the wire about 5-5.5cm from the wire tip.Microscopic observation on the proximal side of the catheter tip found that the torn end of the tip was severely twisted.Strands on the catheter shaft were disarranged due to accumulated torsion.The separated tip was severely twisted for the most part.The very distal end of the separated tip was scratched likely by contacting calcium.In addition, the coil of the guide wire around the separated tip was disarranged.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the provided information and investigation outcome, it was presumed that torsion generated with torqueing the microcatheter in attempts to cross the heavily calcified lesion had most likely contributed to the observed tip separation.The applied stress would localize and therefore exceed the product design limit when the tip was being caught and restricted its movement by the lesion.Sticking of the microcatheter on the guide wire was likely attributed to disarranged coil of the guide wire or narrowed catheter lumen by twisting.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] do not use this microcatheter in advanced calcified lesion.If any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.) 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.) [malfunctions and adverse effects] separation.Trap with guide wire.
Event or Problem Description
It was reported that the tip of an asahi corsair pro xs microcatheter detached during a percutaneous coronary intervention (pci) to treat a heavily calcified 90-95% stenosis in the mid left circumflex artery (lcx).The physician used a non-asahi runthrough wire to cross the mid lcx heavily calcified lesion.First he used a non-asahi turnpike spiral microcatheter but it was unable to advance across lesion.He then tried corsair pro xs.He was unable to advance across the lesion.When he tried to remove the corsair pro xs, he noticed the microcatheter would not come off wire.He pulled the microcatheter and wire out of the guide.He noticed the tip was separated from the shaft and was stuck on the wire.He used another runthrough wire to cross the lesion.Then he used a non-asahi mamba flex microcatheter and tried to cross the lesion but it would not cross the lesion.The patient was fine, no adverse outcomes associated with this event.

• 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: 11391022
• Report Number: 3003775027-2021-00042
• Device Sequence Number: 11054147
• Product Code: DQY
• UDI-Device Identifier: 04547327123662
• UDI-Public: (01)04547327123662(17)230630(10)200720K041
• 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): 02/10/2021

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: 06/30/2023
• Device Catalogue Number: CSR135-21S
• Device Lot Number: 200720K041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1