MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that perforated sheath was noted.Vascular access was obtained via the femoral artery.The 70% stenosed, 70x2.5mm, eccentric, de novo target lesion containing a lesion bend of <=45 degrees was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.The target lesion was pre-dilated with a 2.5x10mm non-bsc balloon catheter.A 1.50 mm rotalink plus was selected for treatment.A non-bsc guidewire was first to cross the lesion and was then exchanged with a rotawire through a microcatheter and inserted the rotalink burr proximal to the target lesion; however, the console stalled.The physician then attempted to conduct rotablation a couple of times; however, the same issue occurred.Upon removal of the device, a small perforation on the catheter was noted.The physician then removed the device completely from the patient's body and completed the procedure with a 32 x 2.50mm promus premier stent deployed distally to lad.A non-bsc stent was also deployed proximally to the target lesion and the thrombolysis in myocardial infarction flow (timi) of 3 was established.There were no patient complications reported and the patient status was good.

Manufacturer Narrative

Device evaluated by mfr.: device returned for analysis.A visual examination of the complaint unit was carried out.The handshake connection was inspected and no issue was noted.Handshake connection test was attempted but no issues were noted.The drive shaft, coil and sheath were inspected and there was no damage noted.The unit was connected to a saline infusion, no issues were noted.The complaint unit was functionally tested.The complaint unit did not reach any speed.The complaint advancer was dismantled and the ultem was found to be melted.A melted ultem is due to the interruption of saline or by insufficient flow of saline used during the preparation of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as reason why complaint is identified as user error and the dfu states: never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer¿.(b)(4).

Event Description

It was reported that perforated sheath was noted.Vascular access was obtained via the femoral artery.The 70% stenosed, 70x2.5mm, eccentric, de novo target lesion containing a lesion bend of <=45 degrees was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.The target lesion was pre-dilated with a 2.5x10mm non-bsc balloon catheter.A 1.50 mm rotalink plus was selected for treatment.A non-bsc guidewire was first to cross the lesion and was then exchanged with a rotawire through a microcatheter and inserted the rotalink burr proximal to the target lesion; however, the console stalled.The physician then attempted to conduct rotablation a couple of times; however, the same issue occurred.Upon removal of the device, a small perforation on the catheter was noted.The physician then removed the device completely from the patient's body and completed the procedure with a 32 x 2.50mm promus premier stent deployed distally to lad.A non-bsc stent was also deployed proximally to the target lesion and the thrombolysis in myocardial infarction flow (timi) of 3 was established.There were no patient complications reported and the patient status was good.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5323710
• MDR Text Key: 34267651
• Report Number: 2134265-2015-09268
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0017986267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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 Age: 65 YR
• Patient Weight: 60