MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX KIT; CATHETER, NEPHROSTOMY

Model Number	M0062101180
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588); Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Anxiety (2328); Unspecified Tissue Injury (4559)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.It was reported that the patient was on its 5 weeks post-partum and was breastfeeding an infant, thus requiring longer anesthetic time and more invasive action during the procedure.The physician was looking to minimize anesthetic, surgical time and trauma with fast access.Dilation was performed using a nephromax balloon kit; however, it was noticed that it is not possible to visualize the device under imaging when a renal sheath was advanced over the balloon.Additionally, the tip of the sheath was kinked and could not reach the stone site.Reportedly, the device was inserted repeatedly into the patient which caused procedural delay, more trauma and bleeding.The device was then removed and the procedure was completed with a non-bsc device.Physician concluded that the sheath may have been impacted with the stone that is why it was not visible under imaging.The patient's condition at the conclusion of the procedure was reported to be stable.However, the patient would require additional time in the hospital to recover, more anesthetic, additional trauma and pain management, along with the medication was the concern of the breast feeding.The patient could also have experienced anxiety with the prolonged separation from her infant and concerns for the medications in her breast milk.
Additional Manufacturer Narrative
Block h6: patient codes e020201, e2330 and e2015 captures the reportable event of patient anxiety, pain and additional trauma requiring treatment and prolonged hospital stay.Patient impact code f14 captures the reportable issue of prolonged hospitalization.Block h10: the device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.Block h11: correction: block h6 (patient codes, impact codes, device codes) and h10.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.It was reported that the patient was on its 5 weeks post-partum and was breastfeeding an infant, thus requiring longer anesthetic time and more invasive action during the procedure.The physician was looking to minimize anesthetic, surgical time and trauma with fast access.Dilation was performed using a nephromax balloon kit; however, it was noticed that it is not possible to visualize the device under imaging when a renal sheath was advanced over the balloon.Additionally, the tip of the sheath was kinked and could not reach the stone site.Reportedly, the device was inserted repeteadly into the patient which caused procedural delay, more trauma and bleeding.The device was then removed and the procedure was completed with a non-bsc device.Physician concluded that the sheath may have been impacted with the stone that is why it was not visible under imaging.The patient's condition at the conclusion of the procedure was reported to be stable.However, the patient would require additional time in the hospital to recover, more anesthetic, additional trauma and pain management, along with the medication was the concern of the breast feeding.The patient could also have experienced anxiety with the prolonged separation from her infant and concerns for the medications in her breast milk.
Additional Manufacturer Narrative
Block h6: patient codes e020201, e2330 and e2015 captures the reportable event of patient anxiety, pain and additional trauma requiring treatment and prolonged hospital stay.Patient impact code f14 captures the reportable issue of prolonged hospitalization.Block h10: investigation result: a visual examination of the returned complaint device found that only the nephromax balloon was returned for analysis, and the renal sheath was not returned with the device.The balloon was returned not folded which indicates that the device was subjected to positive pressure.Functional evaluation was performed and the balloon was inflated to its rated burst pressure of 20 atm for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 20 atm before and after use with a calibrated pressure gauge.The inflation to was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and tactile examination was performed to the tip and shaft, and no damages were found.There were no issues with tip and the shaft.Microscopic analysis was performed to the markerbands and no issues were found.No issues were identified during analysis, thereby the reported failure could not be confirmed.The reported problem is most likely due to the repeated insertion attempts, the sheath may have been impacting on a stone, and applying excessive force to the sheath during insertion attempts could have possible affected the device performance and its intended purpose.Tissue trauma and bleeding are listed as possible adverse effects associated with the use of this device.It was reported that the anxiety experienced by the patient was due to being separated from her 5-week-old infant and concerns for medication in her breast milk.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.Additional information: block d4: the lot number of the nephromax balloon included in the kit is 23881387.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.It was reported that the patient was on its 5 weeks post-partum and was breastfeeding an infant, thus requiring longer anesthetic time and more invasive action during the procedure.The physician was looking to minimize anesthetic, surgical time and trauma with fast access.Dilation was performed using a nephromax balloon kit; however, it was noticed that it is not possible to visualize the device under imaging when a renal sheath was advanced over the balloon.Additionally, the tip of the sheath was kinked and could not reach the stone site.Reportedly, the device was inserted repeatedly into the patient which caused procedural delay, more trauma and bleeding.The device was then removed and the procedure was completed with a non-bsc device.Physician concluded that the sheath may have been impacted with the stone that is why it was not visible under imaging.The patient's condition at the conclusion of the procedure was reported to be stable.However, the patient would require additional time in the hospital to recover, more anesthetic, additional trauma and pain management, along with the medication was the concern of the breast feeding.The patient could also have experienced anxiety with the prolonged separation from her infant and concerns for the medications in her breast milk.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11327259
• Report Number: 3005099803-2021-00511
• Device Sequence Number: 2581340
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0024865927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 03/12/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 02/16/2021; 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention