MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP90620B0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that blade detachment occurred. The 80% stenosed target lesion was located in the moderately tortuous non-calcified subclavian vein. A 6. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon¿ was selected for use along with a 6fr sheath and 0. 018 guidewire. The device was prepped and introduced into the patient. The device was inflated at nominal pressure and some recoil was suspected during applying pressure process. Dilatation was performed five times in the same area at nominal pressure. A good dilatation of the lesion area was obtained. When withdrawing the balloon catheter from the patient's body, it was noted that one blade came off the balloon. No resistance was felt during removal. Consequently, the physician performed fluoroscopy and ct examination and confirmed no blade was left inside the patient's body. Furthermore, the physician performed flushing of the sheath to search for the blade; however, the blade was not found. Lastly, the blade was searched inside the tray after but still not found. There was no abnormality or symptoms observed from the patient. The procedure was completed with this device. No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. A visual and microscopic examination was performed on the returned device. One of the blades and pads were noted to have completely detached from the balloon material. The sheath was not returned for analysis. The balloon was unfolded and solidified inflation medium was noted within the balloon material which indicates it has been subjected to positive pressure. The returned device was attached to an encore inflation unit and positive pressure was applied to inflate the balloon. The balloon could not be inflated due to the presence of solidified inflation medium that was present within the balloon and inflation lumen. The device was soaked in a water bath (shamrock number: 19215) at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made. The device was removed from the bath and the balloon was again attached to an inflation device and subjected to positive pressure when liquid was observed to be leaking from a balloon pinhole at the proximal edge of the distal markerband. An examination of the balloon material identified no issues which could potentially have contributed to this complaint. The rated burst pressure of this pcb device is 10atm. A visual and microscopic examination of the 2cm pcb device identified that the entirety of one of the blades and pads was completely detached from the balloon material. This detached blade and pad were not returned for analysis. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. All other blades were present and fully bonded to the balloon material. No issues were noted with the blades or pads that have contributed to the complaint incident. A visual and tactile examination found no kinks or damage along the shaft of the device. A visual and tactile examination identified no issues with the markerband or tip that could have contributed to the complaint incident. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

It was further reported that it was unknown if an actual balloon rupture occurred during this event. A balloon rupture was not confirmed inside the patient. When the balloon was checked outside the patient, symptoms such as leakage of contrast media from the balloon part were observed. The pressure at burst was unknown exactly.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7407269
• MDR Text Key: 104835142
• Report Number: 2134265-2018-02724
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/01/2019
• Device Model Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Device Lot Number: 0021324397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial