MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SION BLACK; PTCA GUIDE WIRE

Catalog Number APW14R010S

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911 when the reported product was returned to the manufacturer, reportable malfunction was recognized for the first time; therefore, g3.Date received by manufacturer is the same as the date in d9.Returned to manufacturer.The reported sion black guide wire was returned for evaluation.Green and accordion-like shaped resin fragments were intermittently found on the sion black at approximately 25mm to 90mm from the guide wire tip.The ptfe coating was also found linearly peeled off at approximately 1,130mm to 1,250mm from the proximal end of the guide wire.The green resin fragments had the same color as the ptfe coating on the shaft of the returned sion black; therefore, it was concluded that the green objects were the peeled ptfe fragments.Replication test was performed based on known similar events.An unused sion black guide wire was inserted into a metal introducer and intentionally made to contact the distal introducer edge.As a result, similar linear ptfe coating damage that was seen on the returned guide wire was observed on the sion black.The peeled ptfe coating fragments turned out to be accordion-like shaped that was similar to the coating fragments adhered on the returned sion black.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 obtained information and the above investigation outcome, it was presumed that the proximal ptfe coating segment of the subject sion black might have been peeled by strong friction generated with a sharp edge of a concomitant device such as a metal introducer.It was concluded that this event was not attributed to product quality.Although there were reportedly no adverse patient effects, a possibility could not be completely ruled out that some ptfe coating fragment(s) might be left in the patient.No capa will be taken.Instructions for use (ifu) states: [warnings] ~ never use metallic needles or metallic sheaths for insertion and withdrawal of this guide wire.Otherwise, the surface of this guide wire may be damaged significantly.[malfunction and adverse effects] ~ abrasion of the guide wire coating.

Event Description

It was reported that an asahi sion black guide wire was used during a percutaneous coronary intervention (pci) to treat the lesion in the proximal left main trunk (lmt) / left anterior descending artery (lad).After the sion black was removed from the patient anatomy, green foreign objects were found attached on the black coating.There were no patient adverse effects, and the patient was discharged the day after the procedure.

• Brand Name: SION BLACK
• Type of Device: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 17786905
• MDR Text Key: 323891951
• Report Number: 3003775027-2023-00092
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K173277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: APW14R010S
• Device Lot Number: 220530A351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other