MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GLADIUS MONGO 14; PTCA GUIDE WIRE

Catalog Number	AP14R023S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).When the device was returned to the manufacturer, a reportable malfunction was recognized for the first time; therefore, the date of this report and the date received by the manufacturer were considered the date the device returned.The corsair pro xs catheter and the gladius mongo guide wire were returned for evaluation.Tip separation was confirmed on the returned catheter.The separated tip was found on the gladius mongo.Tearing of the tip was located at the junction of tip and shaft segments.Shaft strands were disarranged throughout its length due to accumulated torsion.The catheter lumen became narrowed by the inner jacket (innermost polymer layer) and braid tube that were gathered to the center of the lumen.These findings indicated that torsion had contributed to the observed separation of the tip.The separated tip on the guide wire was approximately 7mm long.The mid-section of the tip was longitudinally stretched where also the tip surface was circumferentially scratched.The proximal section of the tip was twisted.Proximal to the tip, the polymer jacket on the guide wire was scratched, twisted, and partially peeled off.These findings suggested some hard object such as calcified plaque had been in contact with the tip as well as the guide wire during manipulation.The ptfe coated shaft of the guide wire at approximately 57cm from the proximal end was linearly peeled with a spot where the ptfe coating was entirely peeled off.This kind of peeling of the coating is known to be attributed to a metal chuck of a torque device.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 provided information and investigation outcome, it was presumed that torsion had most likely contributed to the observed separation of the tip.The applied stress generated with manipulation would exceed the product design limit when the tip was being caught and restricted its movement likely by calcified cto.Peeling of the polymer jacket on the guide wire was also likely attributed to anatomy.Peeling of the ptfe coating on the guide wire appeared to be attributed to a torque device.It was concluded that this event was not attributed to product quality.Coating damage observed on the returned guide wire suggested that a possibility that some coating fragments might be left in the patient could not be completely rule out.The malfunction and adverse effects section of the instructions for use (ifu) states abrasion of the guide wire coating.
Event or Problem Description
It was reported that the tip of an asahi corsair pro xs microcatheter broke off during a pci to treat a cto in the mid lcx.An asahi gladius mongo guide wire was able to cross the cto.A non-asahi mamba flex microcatheter followed but failed to cross the lesion.The corsair pro xs was then advanced further but not totally across the cto cap.Clockwise and counter clockwise rotations were applied but the corsair pro xs was not advancing any further.Upon removal, it was noticed that the tip of the corsair pro xs broken off and was stuck on the guide wire.The gladius mongo with the separated tip was also removed so that nothing left behind.Attempts were made to rewire the vessel but was unable to advance any microcatheter or balloon through the cto cap.There were no adverse patient effects associated with this event.

• Brand Name: GLADIUS MONGO 14
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10731307
• Report Number: 3003775027-2020-00159
• Device Sequence Number: 3125782
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)221130(10)191209A081
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180784
• 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): 10/12/2020

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: AP14R023S
• Device Lot Number: 191209A081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/23/2020
• 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
• Patient Age: 74 YR