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

Model Number M001BP50520B0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  Injury  

Event Description

It was reported that a blade detachment occurred.The target lesion was located in a moderately tortuous and moderately calcified artery in the forearm.A 5.00mm/2.0cm/50cm otw peripheral cutting balloon¿ was used for dilatation.An unspecified sheath was inserted from the elbow towards the target area.After inflating the device several times, the physician removed the sheath and started to perform echo.The physician then noticed an object near the sheath.The device was then removed from the patient.The device was inflated and it was observed that a blade was detached and remained inside the patient.Surgery was performed and the detached blade was removed.The procedure was not completed due to this event.There were no further complications reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was an intimal thickening.Multiple inflations was performed; however, each inflation was not performed at high pressure.No resistance was encountered upon insertion and removal of the device.Furthermore, the detached blade was noted at the distal end of the introducer sheath inside the patient.The blade was also bent upon removal.Current patient condition was good.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination revealed that an entire blade and blade pad had detached from the balloon.Approximately 2 mm of the proximal end of the blade pad remained attached to the balloon.A visual and microscopic examination observed no damage to the tip.The balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole at 3 mm distal to the distal end of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found that the hypotube was kinked at various positions along its length.This type of damage is consistent with excessive force being applied to the delivery system during device use/handling.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 further reported that the target lesion was an intimal thickening.Multiple inflations was performed however, each inflation was not performed at high pressure.No resistance was encountered upon insertion and removal of the device.Furthermore, the detached blade was noted at the distal end of the introducer sheath inside the patient.The blade was also bent upon removal.Current patient condition was good.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON?
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4751894
• MDR Text Key: 16184200
• Report Number: 2134265-2015-02619
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2017
• Device Model Number: M001BP50520B0
• Device Catalogue Number: BP505020B
• Device Lot Number: 17623023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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
• Treatment: INTRODUCER SHEATH: 7FR
• Patient Outcome(s): Required Intervention