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Model Number U357584 |
Device Problems
Material Rupture (1546); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).Device not returned.
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Event Description
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It was reported that during an angioplasty procedure, the balloon allegedly ruptured and detached.Further reported that the physician removed the detached piece of balloon.There was no reported patient injury.
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Event Description
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It was reported that during an angioplasty procedure, the balloon allegedly ruptured at 18 atm.It was further reported that the balloon allegedly detached and the detached piece of balloon was removed.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned to the manufacturer for evaluation.However, one photo was reviewed.The photo shows the detached part of the catheter along with the portion of the ruptured balloon (compound rupture) attached to it.The ruptured balloon appears bloody.No other specific anomalies noted.Therefore based on the submitted photo, compound balloon rupture and balloon detachment can be confirmed since the detached catheter and ruptured balloon can be seen.Therefore the investigation can be confirmed for the reported balloon rupture since a compound rupture was noted on the balloon.The investigation can be confirmed for the reported detachment since the device is noted to be detached distally.A definitive root cause for the alleged compound balloon rupture and detachment could not be determined based upon the provided information.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 01/2024), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one photo was reviewed.The photo shows the detached distal part of the catheter exposing the inner guide wire lumen along with the portion of the ruptured balloon (circumferential rupture) attached to it.The ruptured balloon appears bloody.No other specific anomalies noted.Therefore based on the submitted photo, balloon rupture and balloon detachment can be confirmed since the detached catheter and ruptured balloon can be seen.One ultraverse035 pta dilatation catheter in two segments has returned for evaluation.On the visual evaluation of the device the segment 1 consist detached distal end of the catheter exposing the inner guide wire lumen and circumferentially ruptured balloon.Segment 2 consist of the remaining part of the catheter.Only the proximal marker band was present.All the anomalies noted on the microscopic observation.No other specific anomalies noted.No functional testing performed due to the condition device.Therefore, the investigation was confirmed for the reported balloon rupture as the returned device has circumferential rupture.The investigation was also confirmed reported detachment as the catheter retuned in 2 segments for evaluation.A definitive root cause for the alleged circumferential balloon rupture and detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 01/2024).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 18 atm.It was further reported that the balloon allegedly detached.Reportedly, another balloon was inflated to remove the detached piece through the introducer.There was no reported patient injury.
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Search Alerts/Recalls
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