As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, image was provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).
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H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: two devices were returned for evaluation.The first sample was noted to be bloody and separated as two segments.The first segments consists of the balloon partial catheter.The second segment consists of the remaining balloon with no anomalies to the bifurcate or glue filets.The second sample was noted to clean and no anomalies were noted.However, due to the nature of the complain the second sample was not evaluated for.One x-ray image was reviewed by dr.Gustav blomquist.The image shows the device being used in the medial arm just above the elbow with some contrast noted to the proximal end.Based on the x-ray the balloon can be noted to be in deflated stated.Based on the medical review, the reported inflation issue can be confirmed for.The investigation is inconclusive for the reported unable to inflate and retraction problem, as the device could not be evaluated due to the nature of the returned sample.The investigation is confirmed for the identified device detachment, as sample one was returned separated as two segments.The reported retraction issue may have contributed to the identified device detachment.However, the definitive root cause for the reported unable to inflate, retraction problem and the identified device detachment could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2023).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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