BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number M004PM47900 |
Device Problems
Bent (1059); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The returned device had a kink approximately 1.5cm from the distal tip between ring 1 and ring 2.There was also a bend located approximately 3.2cm from the distal tip.The seals on ring 1 and ring 2 were compromised, and a piece of the ring 1 seal was missing.The steering knob and tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated and both the right and left curve tests failed.Both curves have an irregular shape due to the kink and bend.X-ray showed a bent center support between rings 1 and 2; it appeared that the center support was bent over itself.There was no evidence of guide coil collapse.The distal section was dissected; there was body fluid in the interior of the sheath.The kevlar wrap was displaced and the center support is bent and fractured.Both steering wires were attached; however, the solder connection to one wire was cracked.The reason for the inability to steer the catheter in the field was due to the fractured center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
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Event Description
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Reportable based on analysis completed (b)(6) 2017.It was reported that during an ablation procedure to treat atrial flutter, the intellatip mifi¿ xp ablation catheter was not able to come in contact properly with the target area, and ¿the potential did not attenuate even though energization was performed.¿ the catheter was removed and ¿the electrode part of no.3-4¿ was bent.The procedure was completed with another of the same device.There were no patient complications.However, returned device analysis revealed the seals on ring 1 and ring 2 were compromised and a piece of the ring 1 seal was missing.
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Search Alerts/Recalls
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