MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 CERE 7MMX30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410073030
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.Procode: krd/hcg.The product lot number was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, the doctor deployed the 7mmx30cm presidio 10 cere coil (pc410073030, unknown lot) through an unknown prowler lp es microcatheter (mc).After deploying the coil fully, the microcatheter kicked back.The doctor tried to reposition the catheter so he tried to pull back and re sheath the coil so that he can reposition the catheter.The doctor had difficulty in pulling back the coil inside the catheter, therefore, after some attempts he pulled both the microcatheter and coil outside the system.Then he repositioned the catheter with the guide wire again and finished the case with competitor¿s coils.The surgery was delayed due to the reported event.The procedure was successfully completed.The device was removed easily without additional intervention.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization, the doctor deployed the 7mmx30cm presidio 10 cere coil (pc410073030, s10951) through an unknown prowler lp es microcatheter (mc).After deploying the coil fully, the microcatheter kicked back.The doctor tried to reposition the catheter so he tried to pull back and re sheath the coil so that he can reposition the catheter.The doctor had difficulty in pulling back the coil inside the catheter, therefore, after some attempts he pulled both the microcatheter and coil outside the system.Then he repositioned the catheter with the guide wire again and finished the case with competitor¿s coils.The surgery was delayed due to the reported event.The procedure was successfully completed.The device was removed easily without additional intervention.There was no patient injury reported.Additional information received indicated that there was no cerebral target loss.Prior to this coil, a few competitive coils were able to advance through the same microcatheter.There had not been blood flow restriction/reduction as a result of the event.The inadequate catheter support did not result in coil herniation, vessel damage, or loss of removal of the catheter from the patient.Adequate flush been maintained through the devices.There was no evidence of physical material within the mc.The target vessel/site was the intracranial artery (ica).A non-sterile unit presidio 10 cere 7mmx30cm was received inside of a pouch.The hub was inspected, and no damages were noted on it.The dpu was inspected and it was found in good normal condition, however it was noted protruded from introducer.The introducer was inspected, and it was found in good normal conditions.The re-sheathing tool was inspected, and it was found in good normal conditions.The v-notch was inspected under microscope and it was found in normal good condition.The rh and the articulation joint were inspected under microscope and they were found in good normal conditions.As well as the rh was not found heated.The embolic coil was inspected under microscope and it was found with a stretch condition.The functional test cannot be performed due to the conditions of the device returned.A manufacturing record evaluation was performed for the finished device s10951 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - withdrawal difficulty-into microcatheter¿ could not be duplicated due the conditions noted on the device.The protruded condition observed on the dpu and the stretch condition noted on the embolic coil may be related to the efforts to retrieve the device back, however this cannot be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided.However, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that there was no cerebral target loss.Prior to this coil, a few competitive coils were able to advance through the same microcatheter.There had not been blood flow restriction/reduction as a result of the event.The inadequate catheter support did not result in coil herniation, vessel damage, or loss of removal of the catheter from the patient.Adequate flush been maintained through the devices.There was no evidence of physical material within the mc.The target vessel/site was the intracranial artery (ica).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: PRESIDIO 10 CERE 7MMX30CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9192585
• Report Number: 2954740-2019-00548
• Device Sequence Number: 14213067
• Product Code: HCG
• UDI-Device Identifier: 00878528003038
• UDI-Public: 00878528003038
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: PC410073030
• Device Lot Number: S10951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 11/06/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/28/2019; 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT LPES