H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2026).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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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 conquest 40 pta dilatation catheter was returned for evaluation.During visual observations fiber disturbance was noted in the balloon.No other anomalies were noted.In the functional testing, negative pressure was applied with an in-house presto inflation device and water leak could be observed in balloon near to the distal tip.Balloon fibers stripped and under microscopic evaluation balloon longitudinal rupture could be noted near to the distal tip.No further testing was performed.No significant evidence of the break was noted during the sample analysis.Upon visual evaluation, fiber disturbance was noted throughout the balloon and no other anomalies were noted, hence the investigation was confirmed for the identified fiber disturbance and the investigation was unconfirmed for the reported break.During functional testing, the device leaked upon inflation, hence the reported balloon leak was confirmed.Further under microscopic evaluation balloon longitudinal rupture could be noted near to the distal tip.Hence, the investigation is confirmed for the reported balloon rupture.The identified balloon rupture might lead to the reported leak.However, the definitive root cause for the reported balloon leak, break and identified fiber disturbance, balloon rupture issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 04/2026), g3, h6 (device, method).H11: section a through f ¿ the information provided 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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