28-sep-2021 pma number was incorrect on the original submission.Corrected to k151744.The returned instrument was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed a fine jet of water emerging from the center of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole with transversal orientation about 62 mm proximal to the distal x-ray marker.At the origin of the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.
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