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

Catalog Number	CSW135-26N
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.The importer report number used for this report was generated from the importer registration number, current year, and sequential number that matches the manufacturer report number.Attempts were made to gather thorough event information during complaint processing; no further information could be obtained.Device investigation could not be conducted as the device was not available.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Although device investigation of the corsair could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency.Based on the provided information, it was inferred that the reported failure to cross and aneurysm enlargement were related to the anatomical condition and device manipulation technique.Instructions for use states: -[warnings] when this microcatheter is placed in vessel, always manipulate it with care by confirming the position of distal end of microcatheter under fluoroscopy.Surface of this microcatheter is provided with hydrophilic coating for lubricity, this microcatheter may happen to be advanced too far toward periphery over the target area of the operator's aim.(the blood vessel and/or the microcatheter may be damaged.); -[warnings] do not use this microcatheter to an advanced calcified lesion; and, -[malfunctions and adverse events] damage to vessel including vessel dissection, vessel perforation and vessel rupture.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient presented with a large aneurysm in a 99 to 100% occluded, heavily calcified lesion in the mid right coronary artery (rca).A non-asahi guide wire was advanced via right common femoral artery access into a non-asahi guiding catheter and crossed the aneurysm into the posterior descending coronary artery with difficulty due to patient anatomy.An attempt was then made to exchange the guide wire for a non-asahi atherectomy wire, but these wires were unable to be exchanged, despite advancement assistance attempted with the subject microcatheter, a 1.25 x 12 mm non-asahi balloon catheter, and a non-asahi spiral catheter.The non-asahi guide wire was, thus, pulled back to a less occluded vessel area to facilitate advancement of another non-asahi guide wire, then a asahi guide wire, using the spiral catheter for advancement support, but, after attempting to cross for an hour, these guide wires were unable to cross the lesion.The lesion was re-wired using a noon-asahi guide wire, followed by advancement of the spiral catheter.Pre-dilatation, atherectomy, additional pre-dilatation, then stenting of the distal rca with a 3.5 x 30 mm stent was then performed.As the aneurysm had become severely enlarged at an unspecified point during the procedure, and was at risk of rupturing, a 4.0 x 19 mm covered stent system was advanced and the stent was deployed at 16 atmospheres (atm) in the mid rca.A 4.5 x 30 mm non-asahi was then deployed proximally at 18 atm.The cover stent was then post-dilated to 18 atm with a 4.5 mm non-asahi balloon; post-dilatation of the other two stents was also performed with this balloon.The aneurysm was excluded and timi flow was iii.The patient had experienced chest pressure during the procedure and mild soreness overnight.As of (b)(6) 2017, the patient is ambulating and feeling well.Patient serum protein is elevated and albumin is low.The patient was discharged home.There were no reported adverse patient sequelae.

• Brand Name: ASAHI CORSAIR
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 6762702
• Report Number: 3003775027-2017-00129
• Device Sequence Number: 11073587
• Product Code: DQY
• UDI-Device Identifier: 04547327087964
• UDI-Public: (01)04547327087964(17)190331(10)170415K041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: Physician
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CSW135-26N
• Device Lot Number: 170415K041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/03/2017
• 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: Required Intervention
• Patient Weight: 73