MAUDE Adverse Event Report: AV-ASAHI ASAHI PROWATER PTCA GUIDE WIRE

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation by asahi is not yet complete.A follow up report will be submitted with all additional relevant information.The xience alpine referenced was filed under a separate medwatch report number.The device is manufactured by asahi intecc.Co.Ltd.(b)(4).Abbott vascular distributes the device and is responsible for mdr reporting.

Event Description

It was reported that a 2.5x33mm xience alpine otw drug-eluting stent (des) system was advanced over an unspecified guide wire (possibly a prowater guide wire) without difficulty for treatment of an unspecified vessel.When pulling the xience alpine system back to position the stent, it became stuck on the guide wire.The stent was also difficult to retract from the lesion.Both the xience alpine otw des system and guide wire were withdrawn as a single unit through the guiding catheter without further reported issue when a stent strut was noted to be fractured.No other damage was noted.There were no adverse patient effects and no occurrence of a clinically significant delay.The target lesion was treated via deployment of an unspecified stent.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Since it was confirmed that the guide wire was not an asahi prowater guide wire or an asahi product, the reported device codes were removed.The initial 30-day medwatch report (mdr) should not have been filed; however, since the initial mdr was filed, the event must remain mdr reportable.Thus, no investigation on the asahi prowater guide wire is required.

Event Description

Subsequent to the previously filed medwatch report, additional information was received noting that the device was not an asahi prowater guide wire.Since this was previously filed, it must remain reportable.

• Brand Name: ASAHI PROWATER PTCA GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-ASAHI; asahi intecc co. ltd med div; 3-100 akatsuki-cho; seto 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI MED SETO, JAPAN REG# 3003775027; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6911355
• MDR Text Key: 89940529
• Report Number: 3003775027-2017-00179
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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