BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939186401510 |
Device Problems
Detachment Of Device Component (1104); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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).
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Event Description
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It was reported that balloon rupture and detachment occurred.
The target lesion was located in the heavily calcified superficial femoral artery (sfa).
A 4.
0mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced to dilate the lesion.
However, upon the first inflation at 10 atmospheres, the balloon ruptured circumferentially and separated from the catheter.
The separated balloon and the tip of the catheter were retrieved using a snare.
The procedure was then completed with a different device.
No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr: the returned product consisted of the emerge balloon catheter in two pieces with a snare device.
The shafts, balloon and tip were microscopically examined.
There was blood in the inflation lumen, guidewire lumen and balloon.
The balloon was loosely folded.
The snare device was attached to the balloon of the device.
Majority of the shaft was buckled and stretched.
The inner shaft that would be within the balloon, had a completed separation and the shaft was torn distally of the separation.
Due to the shaft being stretched, a measurement could not be obtained.
The damage to the shaft indicates that the separation was due to tensile overload.
The balloon was bunched up and had a complete circumferential tear 2 mm distal of the proximal balloon transition.
The tip was damaged.
Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
No other issues were identified during the product analysis.
Device analysis determined the condition of the returned device was consistent with the reported information.
There is no indication that the device was inflated over the rated burst pressure (rbp).
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).
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Event Description
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It was reported that balloon rupture and detachment occurred.
The target lesion was located in the heavily calcified superficial femoral artery (sfa).
A 4.
0mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced to dilate the lesion.
However, upon the first inflation at 10 atmospheres, the balloon ruptured circumferentially and separated from the catheter.
The separated balloon and the tip of the catheter were retrieved using a snare.
The procedure was then completed with a different device.
No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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