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

Model Number H7493932440

Device Problem Fracture (1260)

Patient Problems Infarction, Cerebral (1771); Device Embedded In Tissue or Plaque (3165)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that the wire broke.The 75 % stenosed target lesion was located in the moderately tortuous and mildly calcified distal right coronary artery (rca).The physician crossed the lesion with the comet pressure guidewire.When the physician attempted to deliver the guidewire tip to the 4av peripheral it was unable to advance and often migrated into the thin side branch.In order to capture the 4av main stem, the procedure continued with another physician.After the change in operator, the wire tip continued to migrate into the side branch.The wire fractured and separated 10 cm from the tip.The proximal wire was stuck in the plaque in the shoulder of rca proximal.A non-bsc microsnare was delivered near the peripheral wire distal, and the physician tried to recover the fractured wire by grabbing the coil section of the wire.The wire was successfully grasped but when pulling a few centimeters at the proximal side, the coil tip up to the sensor was disconnected.Although the tip part was recovered from the patient¿s body, the shaft remained inside the patient¿s body.After that, the remaining wire was attempted to be recovered using a snare, but it was unable to catch the wire.The remaining wire that was not able to be removed was pushed by another manufacturer¿s stent.A 3.0 x 38, 3.5 x 38 and 3.5 x 28 non-bsc stents were implanted.A contrast check was performed, and the procedure ended.There was no blood vessel perforation caused by the remaining wire.Following the procedure, the patient had a brain infarction that was confirmed by ct scan 5 hours later.A wait and see approach was taken.3 days later another ct scan was performed.The patient's condition is stable.The patient is expected to recover without "big after-effects".

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a ffr comet wire separated into 2 segments.The proximal shaft and the tip were returned; however, a portion of the device was not returned.The shaft was separated in 1 place.The total proximal shaft length that was returned was 174.5cm.The length of the tip portion returned was 3cm.The tip was also kinked and damaged.There was a segment of the device that was not returned that is approximately 7.5cm long.There was also a slight kink approximately 16cm from the proximal break.No other damage or irregularities were noticed.The sensor port was clear of any blood or material.Device analysis determined the condition of the returned device was consistent with the reported information.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the wire broke.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified distal right coronary artery (rca).The physician crossed the lesion with the comet pressure guidewire.When the physician attempted to deliver the guidewire tip to the 4av peripheral it was unable to advance and often migrated into the thin side branch.In order to capture the 4av main stem, the procedure continued with another physician.After the change in operator, the wire tip continued to migrate into the side branch.The wire fractured and separated 10 cm from the tip.The proximal wire was stuck in the plaque in the shoulder of rca proximal.A non-bsc microsnare was delivered near the peripheral wire distal, and the physician tried to recover the fractured wire by grabbing the coil section of the wire.The wire was successfully grasped but when pulling a few centimeters at the proximal side, the coil tip up to the sensor was disconnected.Although the tip part was recovered from the patient¿s body, the shaft remained inside the patient¿s body.After that, the remaining wire was attempted to be recovered using a snare, but it was unable to catch the wire.The remaining wire that was not able to be removed was pushed by another manufacturer¿s stent.A 3.0x38, 3.5x38 and 3.5x28 non-bsc stents were implanted.A contrast check was performed, and the procedure ended.There was no blood vessel perforation caused by the remaining wire.Following the procedure, the patient had a brain infarction that was confirmed by ctscan 5 hours later.A wait and see approach was taken.Three days later another ct scan was performed.The patient's condition is stable.The patient is expected to recover without "big after-effects".

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that vascular access was obtained via a right radial approach.The lesion was considered to be a "defuse" length.The previously reported separation occurred on the ffr attempt.Bailout was performed with 2 stents.

Manufacturer Narrative

(b)(6).Weight, weight (unit), age at time of event, age at time of event (unit), describe event or problem: updated.(b)(4).

Event Description

It was further reported that the non-bsc guide catheter was noted to be a bit disengaged.No resistance was noted prior to separation.The tip did not get trapped at any point during the procedure.

• 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: 6335165
• MDR Text Key: 67543386
• Report Number: 2134265-2017-01013
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: (01)08714729904403(17)20170731(10)19922764
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 19922764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2017; 04/06/2017; 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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): Required Intervention
• Patient Age: 70 YR