MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a guide wire fractured.Vascular access was obtained via the right radial artery.A non-bsc introducer and non-bsc diagnostic catheter was placed in the patient.The comet was delivered via the non-bsc diagnostic catheter into a tortuous left anterior descending artery (lad) to a 75% stenosed 38mm lesion.The physician attempted to advance comet past lesion and realized wire was not moving.After closer examination, it was noticed that the comet wire was broke in two about 5-6cm from the tip and still in the guide.The physician was able to trap the broke wire into the guide and remove the entire wire and guide.There was no harm to the patient.The procedure was completed with a different wire.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a ffr comet wire separated.The proximal shaft was returned.The distal portion was not returned.The guidewire shaft was examined for any damage or irregularities.The shaft was separated in one place.The total proximal shaft length that was returned was 162cm.The tip portion was not returned.There was approximately 23cm of the device that was not retuned.No other damage or irregularities were noticed.Functional testing of the device could not be completed due to the separation of the shaft.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.Bsc id: (b)(4).

Event Description

It was reported that a guide wire fractured.Vascular access was obtained via the right radial artery.A non-bsc introducer and non-bsc diagnostic catheter was placed in the patient.The comet was delivered via the non-bsc diagnostic catheter into a tortuous left anterior descending artery (lad) to a 75% stenosed 38mm lesion.The physician attempted to advance comet past lesion and realized wire was not moving.After closer examination, it was noticed that the comet wire was broke in two about 5-6cm from the tip and still in the guide.The physician was able to trap the broke wire into the guide and remove the entire wire and guide.There was no harm to the patient.The procedure was completed with a different wire.

Manufacturer Narrative

Device evaluated by mfr: further scanning electron microscopy (sem) revealed no micro cracks were observed in the slots 2 rows adjacent to the proximal fracture.The beam fracture surfaces for the proximal end show fatigue striations toward the center region of fracture.This suggests the possibility of reverse bending with ductile overload.Only the proximal end of fractured device was submitted for analysis.Bsc id # (b)(4) / tw# (b)(4).

Event Description

It was reported that a guide wire fractured.Vascular access was obtained via the right radial artery.A non-bsc introducer and non-bsc diagnostic catheter was placed in the patient.The comet was delivered via the non-bsc diagnostic catheter into a tortuous left anterior descending artery (lad) to a 75% stenosed 38mm lesion.The physician attempted to advance comet past lesion and realized wire was not moving.After closer examination, it was noticed that the comet wire was broke in two about 5-6cm from the tip and still in the guide.The physician was able to trap the broke wire into the guide and remove the entire wire and guide.There was no harm to the patient.The procedure was completed with a different wire.

Manufacturer Narrative

Updated: device evaluated by mfr: the distal portion of the shaft was returned.Additional scanning electron microscopy (sem) no narrow surface/fracture beams are observed.No narrow adjacent beams are observed.There is one crack present on the side of adjacent beam found on the distal specimen.Sides of adjacent beams not imaged on proximal specimen and no micro-cracks are present.This suggests the possibility of reverse bending with ductile overload.(b)(4).

Event Description

It was reported that a guide wire fractured.Vascular access was obtained via the right radial artery.A non-bsc introducer and non-bsc diagnostic catheter was placed in the patient.The comet was delivered via the non-bsc diagnostic catheter into a tortuous left anterior descending artery (lad) to a 75% stenosed 38mm lesion.The physician attempted to advance comet past lesion and realized wire was not moving.After closer examination, it was noticed that the comet wire was broke in two about 5-6cm from the tip and still in the guide.The physician was able to trap the broke wire into the guide and remove the entire wire and guide.There was no harm to the patient.The procedure was completed with a different wire.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6677134
• MDR Text Key: 78700129
• Report Number: 2134265-2017-06351
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: H7495551110
• Device Lot Number: 20427740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2134265
• Patient Sequence Number: 1
• Patient Age: 88 YR