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Model Number D-1220-00 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pneumothorax (2012)
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Event Date 06/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Other company's were used in this study: rf needle (baylis medical, inc., (b)(4)); an 8-fr long sheath (sl0, af division, sjm, (b)(4)); a 28-mm second generation cb (arctic front advance, medtronic, (b)(4)); an 8-mm tip conventional cryocatheter (freezor max, medtronic); a 15-fr steerable sheath (flexcath advance, medtronic); a spiral mapping catheter (achieve, medtronic).(b)(4).The device was not returned to bwi.
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Event Description
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This complaint is from a literature source.It was reported that 1 patient underwent radiofrequency ablation procedure and had pneumothorax during the puncture of the right subclavian vein.Based on the facts of the case and the author's assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title:"durability of cryothermal pulmonary vein isolation - crreating contiguous lesions is necessary for persistent isolation." the purpose of this study aimed to evaluate the impact of the ablation method on the durability of cryothermal pvi.132 consecutive paroxysmal atrial fibrillation patients undergoing cryothermal pvi were enrolled.Suspected device is lasso; however catalog and lot number are unknown.Other company's were used in this study: rf needle (baylis medical, inc., (b)(4)); an 8-fr long sheath (sl0, af division, sjm, (b)(4)); a 28-mm second generation cb (arctic front advance, medtronic, (b)(4)); an 8-mm tip conventional cryocatheter (freezor max, medtronic); a 15-fr steerable sheath (flexcath advance, medtronic); a spiral mapping catheter (achieve, medtronic).
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