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

Model Number H802227680030

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

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 a burr catheter sheath fracture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure the burr began to lose its speed.The burr catheter was removed from the patient and at this time it was noticed that the burr catheter sheath was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device lot number ¿ corrected from 0020452062 to 0019654176.Device expiration date - corrected from 02/28/2019 to 07/31/2018.Device manufactured date - corrected from 03/31/2017 to 08/30/2016.Device evaluated by mfr: the rotalink burr catheter was returned with a rotawire inside the device.A visual and microscopic examination of the handshake connection, burr, and annulus were performed.There was blood in the sheath.The sheath was split/torn 23cm distal of the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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.Bsc id: (b)(4), tw# (b)(4).

Event Description

It was reported that a burr catheter sheath fracture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink¿ burr was selected for use.During the procedure the burr began to lose its speed.The burr catheter was removed from the patient and at this time it was noticed that the burr catheter sheath was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

(b)(4).Device evaluated by mf: corrected from the rotalink burr catheter was returned with a rotawire inside the device.A visual and microscopic examination of the handshake connection, burr, and annulus were performed.There was blood in the sheath.The sheath was split/torn 23cm distal of the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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.- to - device was returned for analysis.Returned product consisted of the rotalink burr catheter device with a rotawire inside the device.An attempt to remove the wire from the catheter was made; however, the rotawire was unable to be removed.A visual and microscopic examination of the coil, sheath, handshake connection, burr, and annulus were performed.There was blood in the sheath.The sheath was split/torn 23cm distal of the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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.Bsc id: (b)(4).Tw#: (b)(4).

Event Description

It was reported that a burr catheter sheath fracture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink¿ burr was selected for use.During the procedure the burr began to lose its speed.The burr catheter was removed from the patient and at this time it was noticed that the burr catheter sheath was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: ROTALINK¿ BURR
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6693611
• MDR Text Key: 79288493
• Report Number: 2134265-2017-07061
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)20190228(10)0020452062
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• 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
• Report Date: 06/27/2017

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: 07/31/2018
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 0019654176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 07/19/2017; 07/19/2017
• Supplement Dates FDA Received: 08/04/2017; 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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