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

Model Number H749236310020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 12/02/2014

Event Type  Injury  

Event Description

It was reported that a vessel dissection occurred.Vascular access was obtained via the right radial artery.The 23 x 2.5mm, 80% stenosed, eccentric, denovo, target lesion was located in a moderately tortuous, moderately calcified, mid left anterior descending artery (lad).The lesion had a significant bend between 45 and 90 degrees.A 6f 3.0 mm guide catheter and non-bsc guide wire were introduced.Pre dilatation was performed using a 2.5x8 non-bsc balloon but the balloon was unable to open the lesion.A 2x10mm total occlusion balloon was then introduced but the lesion still did not open due to calcification.The non-bsc guide wire was exchanged for a rota floppy wire.A 1.5mm rotalink¿ plus was introduced but it was not able to ablate.A 1.25mm rotalink¿ plus was then introduced.Restriction was felt and the device was used for 6 minutes.The physician noted a vessel dissection happening and abandoned the procedure.The patient was sent for coronary artery bypass graft (cabg).

Manufacturer Narrative

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).

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was returned for analysis.A visual examination of the complaint unit was carried out.The advancer knob was locked upon return in a backward position, it was loosened and advanced in order to inspect the handshake connection.The handshake connection of the catheter was not connected to the handshake connection of the advancer.The handshake connection of the advancer was inspected and no damage was noted.The handshake connector was contained within the sheath of the catheter.The sheath was cut and the handshake connector was exposed.The coil was observed to be kinked upon inspection.The handshake connection of the catheter was inspected and was observed to be bent upon inspection.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 a vessel dissection occurred.Vascular access was obtained via the right radial artery.The 23 x 2.5mm, 80% stenosed, eccentric, denovo, target lesion was located in a moderately tortuous, moderately calcified, mid left anterior descending artery (lad).The lesion had a significant bend between 45 and 90 degrees.A 6f 3.0 mm guide catheter and non-bsc guide wire were introduced.Pre dilatation was performed using a 2.5x8 non-bsc balloon but the balloon was unable to open the lesion.A 2x10mm total occlusion balloon was then introduced but the lesion still did not open due to calcification.The non-bsc guide wire was exchanged for a rota floppy wire.A 1.5mm rotalink¿ plus was introduced but it was not able to ablate.A 1.25mm rotalink¿ plus was then introduced.Restriction was felt and the device was used for 6 minutes.The physician noted a vessel dissection happening and abandoned the procedure.The patient was sent for coronary artery bypass graft (cabg).

• 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: 4347098
• MDR Text Key: 18892137
• Report Number: 2134265-2014-08025
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016576528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• 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
• Treatment: BMW 0.014 GUIDE WIRE; ACROSS CTO 2X10MM BALLOON CATHETER; XB 3.0 GUIDE CATHETER; ACROSS GRIP 2.5X8MM BALLOON
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 60